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DeGen Standard Instrumentation

FDA UDI

Class I (US FDA UDI)

by Degen Medical

Identity

Trade Name
DeGen Standard Instrumentation FDA UDI
Generic Name
Neurosurgical retraction system, spinal FDA UDI
Device Name
Retractor Assy FDA UDI
Model / Reference
97-01R FDA UDI
Description
Retractor Assy FDA UDI

Identifiers

Catalog Number
97-01R FDA UDI
Primary DI / UDI-DI
00842048153917 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Neurosurgical retraction system, spinal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Neurosurgical retraction system, spinal

DeGen Standard Instrumentation by Degen Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical retraction system, spinal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Degen Medical

Sources (1)

  • FDA UDI cc68717f-323b-42d6-b7ff-6cf7e1958d3b 35 fields · synced May 30, 2026